Adenovirus Antigen Fluorescence Rapid Test Cassette (Swab)

Trade name

Adenovirus Antigen Fluorescence Rapid Test Cassette (Swab)

UDI-DI code

D-FCADE-502aMC

Basic UDI-DI

B-FCADE-502aMC

Reference / catalog number

FCADE-502a

Issuing entity

EUDAMED

Risk category

IVDD — General

Applicable legislation

IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]

Status

On the market

Quantity

1

Additional product description

The Adenovirus Antigen Fluorescence Rapid Test Cassette (Swab) is a rapid fluorescence immunoassay for the qualitative detection of adenovirus antigen in human nasal/nasopharyngeal swab, nasal/nasopharyngeal aspirate samples. It intended as a screening test and as an aid in the diagnosis of adenovirus respiratory infections. For in vitro diagnostic use only. For professional use only.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

European Medical Device Nomenclature — the EU product classification assigned to this device.

• W0105040601ADENOVIRUS

2 warnings recorded — scroll inside the panel to see all entries.

• CW010

  EUDAMED did not publish a description for this code.
• CW009

  EUDAMED did not publish a description for this code.

No certificate specifically references this device's Basic UDI-DI.